Singapore's ASLAN gets second U.S. FDA orphan designation for ASLAN001

FDA sign

Singapore-based ASLAN Pharmaceuticals said its pan-HER inhibitor varlitinib (ASLAN001) has received a U.S. FDA orphan designation for a second indication in gastric cancer, the third most common cancer in Asia.

The biotech won its first orphan designation for ASLAN001 in August of last year for a treatment for cholangiocarcinoma, a rare and aggressive form of bile duct cancer. The approval came after the candidate announced plans to work with Taiwan's ACT Genomics to explore a better-than-expected therapeutic response in which one patient showed 87% tumor shrinkage over a prolonged period of time.

ASLAN, which received Phase II trial nods for the candidate in Singapore and Taiwan last year, has also signed a pact with South Korea's Hyundai Pharmaceutical for the first co-development agreement on ASLAN001.

Also last year, ASLAN notched up positive Phase I results with gastric cancer candidate ASLAN002, licensed from Bristol-Myers Squibb ($BMY). The drug is heading to Phase II.

The company also has preclinical candidate ASLAN003, a DHODH inhibitor, licensed from Almirall, currently in Phase I trials for rheumatoid arthritis, and ASLAN004, a fully human monoclonal antibody against interleukin-13 receptor α1 that has been shown to block binding and signal transduction of both IL4 and IL13, which was licensed from CSL.

In 2015, ASLAN secured $22 million in Series B financing led by Shanghai-based Cenova Ventures, which joined Morningside Group and XinChen Ventures with BioVeda Capital and Sagamore Bioventures, to fund ongoing clinical development of ASLAN's portfolio.

Sources said the company is eyeing raising more capital and eventually listing in either Asia or the U.S.

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ASLAN gets U.S. FDA orphan designation on ASLAN001